N/A
N=57
Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
Breast Neoplasms · Carcinoma, Ductal · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00321048 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score — 1.2; 2.0; 2.1; 2.5 Mean Perfusion Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Breathing Coordinator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score |
1.2; 2.0; 2.1; 2.5 | — |
Summary
Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.
Eligibility Criteria
Inclusion Criteria
- Patient must be 18 and older
- Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.
- Patients must have undergone a segmental mastectomy (SM) or Mastectomy
- Patients must not have received prior radiation therapy to the breast at any time for any reason.
- Any patient with active local-regional disease prior to registration is not eligible.
- Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.
- Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
Data sourced from ClinicalTrials.gov (NCT00321048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.